There is a lack of key performance indicator wavelength requirements in the quality agreement between the company and the laser tube (Class A material) supplier.

The carbon dioxide laser treatment machine registered product standard stipulates that the product aiming light wavelength should be 635nm±20nm, but the company has not formulated corresponding inspection specifications according to this requirement, and is not equipped with corresponding testing equipment.

The enterprise product release authorization stipulates that the enterprise management representative has the right to release the final product, but the actual document is signed by the unqualified document control personnel, and there is no relevant authorization document; the product inspection releaser in the product release approval form The person in charge of the quality inspection department shall review the signature, but check the serial number product record. The actual signatory is the person in charge of the production department, which is inconsistent with the document.

After the company received the national unqualified report on September 8, 2017, it has not carried out relevant review activities.

The enterprise has confirmed the defects of the above quality management system. The above behavior of the enterprise does not comply with the relevant regulations of the medical device production quality management regulations, and the production quality management system has serious defects. drug The Supervisory Authority instructed the Shanghai Food and Drug Administration to order the enterprise to immediately suspend production and rectification according to law.medical instruments The Regulations on Supervision and Administration (State Council Order No. 680) and related laws and regulations shall be dealt with severely according to law.

The notice is as follows:

First, equipment aspects

enterprise The vernier caliper calibration procedure stipulates that the calibration shall be carried out once a year. However, a numbered vernier caliper is not verified as required, and the enterprise that is not in compliance with the "Medical Device Production Quality Management Regulations" (hereinafter referred to as the "Specification") shall be equipped with appropriate measuring instruments. The range and accuracy should meet the requirements for use, indicate the validity period of the calibration, and save the requirements of the corresponding records.

Second, document management

The performance of the laser was tested in the production process of the enterprise, but the relevant raw data was not recorded. The enterprise that should not establish the record control procedure in the Code, including the identification, storage, retrieval, shelf life and disposal requirements of the record, etc. Satisfying records should ensure traceability requirements for product production, quality control and other activities.

three, purchase aspect

The quality agreement signed by the enterprise and the laser tube (class A material) supplier lacks the wavelength of the key performance indicator. The enterprise that does not meet the requirements of the "regulation" should sign a quality agreement with the main raw material supplier to clarify the requirements of the quality responsibility of both parties. .

Fourth, quality control

(1) The registered product standard of the enterprise CO2 laser treatment machine stipulates that the wavelength of the aiming light of the product should be 635nm±20nm, but the enterprise has not formulated the corresponding inspection procedures, and is not equipped with the corresponding testing equipment, and the enterprises that do not meet the “Specifications” shall be in accordance with the mandatory standards and The technical requirements of the products registered or filed shall be formulated with the inspection procedures of the products, and the corresponding inspection reports or certificates shall be issued.

(2) The enterprise product release authorization stipulates that the enterprise management representative has the right to release the final product, but the actual document is signed by the unqualified document control personnel, and there is no relevant authorization document; the product in the product release approval form The inspection release person shall be examined and signed by the person in charge of the quality inspection department, but the serial number of the product record shall be checked. The actual signatory shall be the person in charge of the production department, which is inconsistent with the provisions of the document. The enterprise shall stipulate the product release procedure, conditions and release in the “Code”. Approval requirements.

Five, non-conforming product control

After receiving the unqualified result of the product country, the enterprise said that it has returned to the user of the sold product, but failed to provide the return visit record. If the product is not qualified after the product is sold in the “Code”, the enterprise shall promptly take corresponding action. The requirements of the measures.

Six, adverse event monitoring, analysis and improvement

After receiving the national unqualified report on September 8, 2017, the company has not carried out relevant review activities. Enterprises that do not meet the "Specifications" should conduct regular management reviews and evaluate and review the quality management system to ensure its continued Suitability, sufficiency and effectiveness requirements.

The enterprise has confirmed the defects of the above quality management system. The above behavior of the enterprise does not comply with the relevant regulations of the medical device production quality management regulations, and the production quality management system has serious defects. The State Drug Administration is responsible for the Shanghai Food and Drug Administration. Ordered the company to immediately suspend production and rectification, in violation of the Medical Device Supervision and Administration Regulations (State Council Order No. 680) and related laws Regulation At the same time, the Shanghai Food and Drug Administration is required to require the enterprise to assess the product safety risks. In case of potential safety hazards, it should be in accordance with the “Administrative Measures for Medical Device Recall” (Order No. 29 of the State Food and Drug Administration) No.), recall related products.

After the company has completed the rectification of all the projects and has passed the follow-up review by the Shanghai Food and Drug Administration, the production can be resumed. The Shanghai Municipal Bureau should promptly report the recall of the products and the resumption of production and resumption of production to the equipment regulatory department of the State Drug Administration.